Japanese Pharmacopoeia - Draft Chapter of alternative Endotoxin Testing
![Bioburden - Live Online Training](files/eca/userImages/training.img/Z-ECA-Bioburden-LOT.jpg)
Recommendation
15/16 October 2024
Regulatory Expectations and Practical Experiences
Background
For quite some time now, questions such as "What happens if the Limulus populations are damaged, e.g. by environmental changes? or "Should we not, as far as possible, reduce the use of the animals" have been increasingly raised in the area of testing for endotoxins. In this context, the use of alternative test methods or recombinant reagents is gaining in importance. This is also reflected in the development of Pharmacopoeias in Europe, Japan and the USA. We reported about the European Pharmacopoeia (Ph. Eur.) draft chapter - 2.6.32. Test for bacterial endotoxins with recombinant factor C (rFC) which was published in spring for commenting and the USP chapter <85> Bacterial Endotoxin test is under discussion to.
Current JP Draft
The Japanese Pharmacopoeia recently published a draft of a new chapter for comment. "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin Assay". The alternative test discussed in the document is based on the fact that factor C plays an important role in the endotoxin reaction with the classic LAL reagent - a coagulation reaction in the form of a reaction cascade with various serine proteases. This factor can also be produced recombinantly and serve as the basis for an alternative test system.
The present chapter deals accordingly with the existing systems, the possible alternatives and the requirements that are relevant for the conversion. After the Japanese version there is now an English version of the draft available. The draft is open for comment until 30 October.
Fore more details please read "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin Assay".
Related GMP News
05.06.2024Handling of Microbiological Deviations and Sterility Testing - FDA publishes Warning Letter
07.05.2024HTS/NGS - Draft Ph.Eur. Chapter "High-Throughput Sequencing for detecting Viral Extraneous Agents"
31.01.2024EMA publishes new questions and answers on Annex 1
21.11.2023Interpretation of Annex 1 - Swissmedic publishes Q&A Document
16.02.2023Pyrogenicity Testing - European Pharmacopoeia continues to be updated
15.02.2023Warning Letter and Recall of a homeopathic Medicine for Children